Global Clinical Program Lead (GCPL), Type 1 Diabetes, Immunology Cell Therapy

Job Profile: Global Clinical Program Lead (GCPL), Type 1 Diabetes, Immunology Cell Therapy

Location: Office based role in Boston Seaport MA, USA

Are you a visionary expert in clinical drug development, possessing the capabilities to drive a successful strategy in accelerating the development of cellular therapies for patients with immune-mediated diseases? Are you dedicated to revolutionizing the treatment of immune-mediated diseases and creating a significant impact on patients' lives? Do you have a strong passion for science and substantial clinical development experience in Immunology and CAR-T cell therapies? Do you possess both strategic and operational leadership skills? If so, we invite you to join us! We are currently seeking a Global Clinical Program Lead, Immunology Cell Therapy to be based in Boston Seaport.

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. We are more than one of the world’s leading pharmaceutical companies.

Immunology Cell Therapy

Our ambition is to build a world class organization that accelerates the delivery of transformative cell therapies for patients with immune mediated diseases. It’s our big vision that unites and inspires us. Cell therapies represent a fundamental evolution of how drugs are discovered, developed and manufactured, these new advanced potentially curative cellular modalities require a new development strategy to ensure their rapid availability to patients. With multiple autoimmune and inflammatory indications and clinical stage cell therapies in global development, we keep pushing forward.  Focusing on cutting-edge science with the latest technology to achieve breakthroughs.   AZ is a place built on courage, curiosity and collaboration – we make bold decisions driven by patient outcomes.

What You’ll Do

The Global Clinical Physician Lead, Type 1 Diabetes holds an expert position within the new and dynamic immunology cell therapy organization at AstraZeneca. This is an exceptionally exciting and prestigious role, contributing significantly to AstraZeneca's global objectives and the value targets of our portfolio. Reporting directly to the Global Clinical Head of Immunology Cell Therapy in Boston, this individual will also be a pivotal member of the clinical team. As the Global clinical Physician Lead, they are responsible for spearheading the Type 1 Diabetes program and related studies in immune-mediated diseases. Moreover, this role offers the unique opportunity to collaborate closely with cross-functional teams at the enterprise level, including Oncology, Alexion, and several development partners, thereby enhancing the overall impact and reach of the position.

Responsibilities:

• Provide expert medical and scientific input to cell therapy clinical stage assets in development for Type 1 diabetes
• Accountable for clinical scientific aspects of the cell therapies in autoimmune indications, including the benefit/risk of a product and/or asset as well as the scientific strategies for clinical components of the Target Product Profile (TPP), Target Product Claim (TPC), Clinical Development Plan (CDP), Clinical components of regulatory documents, medical monitoring and ensuring timely delivery of studies.
• Provide impactful medical strategy and cell therapy expertise to Research, Translational Medicine and Commercial Partners, including in the development of therapeutic area strategy
• Work closely and collaborate across early and late clinical development, partner functions and wider AZ organization in Oncology and rare disease to ensure design and delivery of clinical development plans with high quality and speed

Essential Skills/Experience:

• An MD, or other equivalent degree from an accredited university or an MD or equivalent degree plus a PhD, with experience in the autoimmune area ideally with cell therapy expertise.
• 5 or more years of industry or combined academic/industry experience in clinical development.
• Significant experience in early and/or late phase clinical development.
• Significant experience in the authoring of relevant regulatory documents.
• Detailed understanding of the full drug development process.
• Adaptive problem solving and learning and ability to navigate complex organizations and systems
• Ability to influence both high level internal and external stakeholders. 
• Ability to frame clear & succinct messages and simplify complexity of decision making.
• Track record of leading successful high performing glob